Trial Outcomes & Findings for RECOVER-NEURO: Platform Protocol, Appendix_A to Measure the Effects of BrainHQ, PASC CoRE and tDCS Interventions on Long COVID Symptoms (NCT NCT05965739)
NCT ID: NCT05965739
Last Updated: 2026-08-11
Results Overview
Everyday Cognition 2 (ECog2) is a self-report, 41-item questionnaire used to measure the participant's perceived capacity to perform activities related to cognitive function, which could impact major activities of daily living and independence. Score ranges from 1 to 5, with 5 being worst.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
328 participants
Primary outcome timeframe
Baseline to End of Intervention (EOI) (Day 70)
Results posted on
2026-08-11
Participant Flow
Participant milestones
| Measure |
BrainHQ Active Comparator
5 sessions/week at 30 min/session
BrainHQ/Active Comparator Activity: BrainHQ platform provides a set of cognitive activities, like puzzles and games, that are cognitively stimulating and actively engage participants but do not continuously and adaptively challenge them. These activities are designed to be a face-valid, active comparison approach to cognitive therapy, thus participants are blinded, attention time is matched, and overall user experience is identical to the active arms.
|
BrainHQ
5 sessions/week at 30 min/session
BrainHQ: BrainHQ is an online cognitive training program, and has been used to improve cognitive function among persons with cognitive impairment based on principles of neuroplasticity.
|
BrainHQ + PASC CoRE
BrainHQ plus 9 group sessions at 1.5 hr/session and 3 individual sessions at 1 hr/session
BrainHQ: BrainHQ is an online cognitive training program, and has been used to improve cognitive function among persons with cognitive impairment based on principles of neuroplasticity.
PASC CoRE: PASC CoRE is a manualized, adaptable cognitive rehabilitation intervention adapted from Goal Management Training and other evidence based programs that improve attention and executive functions, among other cognitive domains.
|
Brain HQ + tDCS-active
2.0 mA stimulation delivered for 30 min during each BrainHQ session
BrainHQ: BrainHQ is an online cognitive training program, and has been used to improve cognitive function among persons with cognitive impairment based on principles of neuroplasticity.
tDCS-active: Transcranial direct current stimulation (tDCS) will use a device specifically for home-based use. This device delivers a weak electrical current of 2.0 mA passed through two electrodes placed on the scalp to target the dorsolateral prefrontal cortex region of the brain. The electrodes are single-use for each session and can be attached to a headset by snapping into place.
The device has a user-friendly interface and a large-button keypad, making it is easy to use at home.
|
Brain HQ + tDCS-sham
Inactive stimulation delivered for 30 min during each BrainHQ session
BrainHQ: BrainHQ is an online cognitive training program, and has been used to improve cognitive function among persons with cognitive impairment based on principles of neuroplasticity.
tDCS-sham: tDCS devices used in the sham arm will be pre-programmed to deliver the same ramp up/down at the beginning/end of the 30-minute period as the active arm, except with no current otherwise delivered during the session.
|
|---|---|---|---|---|---|
|
Overall Study
STARTED
|
64
|
67
|
66
|
66
|
65
|
|
Overall Study
COMPLETED
|
59
|
62
|
62
|
55
|
58
|
|
Overall Study
NOT COMPLETED
|
5
|
5
|
4
|
11
|
7
|
Reasons for withdrawal
| Measure |
BrainHQ Active Comparator
5 sessions/week at 30 min/session
BrainHQ/Active Comparator Activity: BrainHQ platform provides a set of cognitive activities, like puzzles and games, that are cognitively stimulating and actively engage participants but do not continuously and adaptively challenge them. These activities are designed to be a face-valid, active comparison approach to cognitive therapy, thus participants are blinded, attention time is matched, and overall user experience is identical to the active arms.
|
BrainHQ
5 sessions/week at 30 min/session
BrainHQ: BrainHQ is an online cognitive training program, and has been used to improve cognitive function among persons with cognitive impairment based on principles of neuroplasticity.
|
BrainHQ + PASC CoRE
BrainHQ plus 9 group sessions at 1.5 hr/session and 3 individual sessions at 1 hr/session
BrainHQ: BrainHQ is an online cognitive training program, and has been used to improve cognitive function among persons with cognitive impairment based on principles of neuroplasticity.
PASC CoRE: PASC CoRE is a manualized, adaptable cognitive rehabilitation intervention adapted from Goal Management Training and other evidence based programs that improve attention and executive functions, among other cognitive domains.
|
Brain HQ + tDCS-active
2.0 mA stimulation delivered for 30 min during each BrainHQ session
BrainHQ: BrainHQ is an online cognitive training program, and has been used to improve cognitive function among persons with cognitive impairment based on principles of neuroplasticity.
tDCS-active: Transcranial direct current stimulation (tDCS) will use a device specifically for home-based use. This device delivers a weak electrical current of 2.0 mA passed through two electrodes placed on the scalp to target the dorsolateral prefrontal cortex region of the brain. The electrodes are single-use for each session and can be attached to a headset by snapping into place.
The device has a user-friendly interface and a large-button keypad, making it is easy to use at home.
|
Brain HQ + tDCS-sham
Inactive stimulation delivered for 30 min during each BrainHQ session
BrainHQ: BrainHQ is an online cognitive training program, and has been used to improve cognitive function among persons with cognitive impairment based on principles of neuroplasticity.
tDCS-sham: tDCS devices used in the sham arm will be pre-programmed to deliver the same ramp up/down at the beginning/end of the 30-minute period as the active arm, except with no current otherwise delivered during the session.
|
|---|---|---|---|---|---|
|
Overall Study
Adverse Event
|
0
|
1
|
0
|
1
|
3
|
|
Overall Study
Lost to Follow-up
|
2
|
0
|
1
|
1
|
1
|
|
Overall Study
Withdrawal by Subject
|
2
|
2
|
1
|
5
|
0
|
|
Overall Study
Disease relapse
|
1
|
0
|
1
|
0
|
0
|
|
Overall Study
Failure to meet randomization criteria
|
0
|
1
|
0
|
1
|
0
|
|
Overall Study
Unable to return for study visits
|
0
|
1
|
0
|
3
|
1
|
|
Overall Study
Early termination
|
0
|
0
|
1
|
0
|
0
|
|
Overall Study
Reported unwanted symptoms
|
0
|
0
|
0
|
0
|
1
|
|
Overall Study
Did not want to be randomized to intervention
|
0
|
0
|
0
|
0
|
1
|
Baseline Characteristics
RECOVER-NEURO: Platform Protocol, Appendix_A to Measure the Effects of BrainHQ, PASC CoRE and tDCS Interventions on Long COVID Symptoms
Baseline characteristics by cohort
| Measure |
BrainHQ Active Comparator
n=64 Participants
5 sessions/week at 30 min/session
BrainHQ/Active Comparator Activity: BrainHQ platform provides a set of cognitive activities, like puzzles and games, that are cognitively stimulating and actively engage participants but do not continuously and adaptively challenge them. These activities are designed to be a face-valid, active comparison approach to cognitive therapy, thus participants are blinded, attention time is matched, and overall user experience is identical to the active arms.
|
BrainHQ
n=67 Participants
5 sessions/week at 30 min/session
BrainHQ: BrainHQ is an online cognitive training program, and has been used to improve cognitive function among persons with cognitive impairment based on principles of neuroplasticity.
|
BrainHQ + PASC CoRE
n=66 Participants
BrainHQ plus 9 group sessions at 1.5 hr/session and 3 individual sessions at 1 hr/session
BrainHQ: BrainHQ is an online cognitive training program, and has been used to improve cognitive function among persons with cognitive impairment based on principles of neuroplasticity.
PASC CoRE: PASC CoRE is a manualized, adaptable cognitive rehabilitation intervention adapted from Goal Management Training and other evidence based programs that improve attention and executive functions, among other cognitive domains.
|
Brain HQ + tDCS-active
n=66 Participants
2.0 mA stimulation delivered for 30 min during each BrainHQ session
BrainHQ: BrainHQ is an online cognitive training program, and has been used to improve cognitive function among persons with cognitive impairment based on principles of neuroplasticity.
tDCS-active: Transcranial direct current stimulation (tDCS) will use a device specifically for home-based use. This device delivers a weak electrical current of 2.0 mA passed through two electrodes placed on the scalp to target the dorsolateral prefrontal cortex region of the brain. The electrodes are single-use for each session and can be attached to a headset by snapping into place.
The device has a user-friendly interface and a large-button keypad, making it is easy to use at home.
|
Brain HQ + tDCS-sham
n=65 Participants
Inactive stimulation delivered for 30 min during each BrainHQ session
BrainHQ: BrainHQ is an online cognitive training program, and has been used to improve cognitive function among persons with cognitive impairment based on principles of neuroplasticity.
tDCS-sham: tDCS devices used in the sham arm will be pre-programmed to deliver the same ramp up/down at the beginning/end of the 30-minute period as the active arm, except with no current otherwise delivered during the session.
|
Total
n=328 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|
|
Age, Continuous
|
44.5 years
n=54 Participants
|
49.0 years
n=54 Participants
|
53.0 years
n=27 Participants
|
47.0 years
n=26 Participants
|
49.0 years
n=161 Participants
|
48.0 years
n=120 Participants
|
|
Sex: Female, Male
Female
|
52 Participants
n=54 Participants
|
49 Participants
n=54 Participants
|
49 Participants
n=27 Participants
|
46 Participants
n=26 Participants
|
45 Participants
n=161 Participants
|
241 Participants
n=120 Participants
|
|
Sex: Female, Male
Male
|
12 Participants
n=54 Participants
|
18 Participants
n=54 Participants
|
17 Participants
n=27 Participants
|
20 Participants
n=26 Participants
|
20 Participants
n=161 Participants
|
87 Participants
n=120 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
6 Participants
n=54 Participants
|
12 Participants
n=54 Participants
|
9 Participants
n=27 Participants
|
11 Participants
n=26 Participants
|
14 Participants
n=161 Participants
|
52 Participants
n=120 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
57 Participants
n=54 Participants
|
55 Participants
n=54 Participants
|
56 Participants
n=27 Participants
|
55 Participants
n=26 Participants
|
51 Participants
n=161 Participants
|
274 Participants
n=120 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=54 Participants
|
0 Participants
n=54 Participants
|
1 Participants
n=27 Participants
|
0 Participants
n=26 Participants
|
0 Participants
n=161 Participants
|
2 Participants
n=120 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=54 Participants
|
2 Participants
n=54 Participants
|
1 Participants
n=27 Participants
|
0 Participants
n=26 Participants
|
0 Participants
n=161 Participants
|
4 Participants
n=120 Participants
|
|
Race (NIH/OMB)
Asian
|
2 Participants
n=54 Participants
|
2 Participants
n=54 Participants
|
6 Participants
n=27 Participants
|
2 Participants
n=26 Participants
|
3 Participants
n=161 Participants
|
15 Participants
n=120 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
1 Participants
n=54 Participants
|
0 Participants
n=54 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=26 Participants
|
0 Participants
n=161 Participants
|
1 Participants
n=120 Participants
|
|
Race (NIH/OMB)
Black or African American
|
6 Participants
n=54 Participants
|
12 Participants
n=54 Participants
|
7 Participants
n=27 Participants
|
10 Participants
n=26 Participants
|
12 Participants
n=161 Participants
|
47 Participants
n=120 Participants
|
|
Race (NIH/OMB)
White
|
47 Participants
n=54 Participants
|
46 Participants
n=54 Participants
|
49 Participants
n=27 Participants
|
50 Participants
n=26 Participants
|
43 Participants
n=161 Participants
|
235 Participants
n=120 Participants
|
|
Race (NIH/OMB)
More than one race
|
5 Participants
n=54 Participants
|
3 Participants
n=54 Participants
|
2 Participants
n=27 Participants
|
3 Participants
n=26 Participants
|
2 Participants
n=161 Participants
|
15 Participants
n=120 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=54 Participants
|
2 Participants
n=54 Participants
|
1 Participants
n=27 Participants
|
1 Participants
n=26 Participants
|
5 Participants
n=161 Participants
|
11 Participants
n=120 Participants
|
|
Region of Enrollment
United States
|
64 Participants
n=54 Participants
|
67 Participants
n=54 Participants
|
66 Participants
n=27 Participants
|
66 Participants
n=26 Participants
|
65 Participants
n=161 Participants
|
328 Participants
n=120 Participants
|
PRIMARY outcome
Timeframe: Baseline to End of Intervention (EOI) (Day 70)Population: Participants with data collected.
Everyday Cognition 2 (ECog2) is a self-report, 41-item questionnaire used to measure the participant's perceived capacity to perform activities related to cognitive function, which could impact major activities of daily living and independence. Score ranges from 1 to 5, with 5 being worst.
Outcome measures
| Measure |
BrainHQ Active Comparator
n=61 Participants
5 sessions/week at 30 min/session
BrainHQ/Active Comparator Activity: BrainHQ platform provides a set of cognitive activities, like puzzles and games, that are cognitively stimulating and actively engage participants but do not continuously and adaptively challenge them. These activities are designed to be a face-valid, active comparison approach to cognitive therapy, thus participants are blinded, attention time is matched, and overall user experience is identical to the active arms.
|
BrainHQ
n=62 Participants
5 sessions/week at 30 min/session
BrainHQ: BrainHQ is an online cognitive training program, and has been used to improve cognitive function among persons with cognitive impairment based on principles of neuroplasticity.
|
BrainHQ + PASC CoRE
n=63 Participants
BrainHQ plus 9 group sessions at 1.5 hr/session and 3 individual sessions at 1 hr/session
BrainHQ: BrainHQ is an online cognitive training program, and has been used to improve cognitive function among persons with cognitive impairment based on principles of neuroplasticity.
PASC CoRE: PASC CoRE is a manualized, adaptable cognitive rehabilitation intervention adapted from Goal Management Training and other evidence based programs that improve attention and executive functions, among other cognitive domains.
|
Brain HQ + tDCS-active
n=55 Participants
2.0 mA stimulation delivered for 30 min during each BrainHQ session
BrainHQ: BrainHQ is an online cognitive training program, and has been used to improve cognitive function among persons with cognitive impairment based on principles of neuroplasticity.
tDCS-active: Transcranial direct current stimulation (tDCS) will use a device specifically for home-based use. This device delivers a weak electrical current of 2.0 mA passed through two electrodes placed on the scalp to target the dorsolateral prefrontal cortex region of the brain. The electrodes are single-use for each session and can be attached to a headset by snapping into place.
The device has a user-friendly interface and a large-button keypad, making it is easy to use at home.
|
Brain HQ + tDCS-sham
n=59 Participants
Inactive stimulation delivered for 30 min during each BrainHQ session
BrainHQ: BrainHQ is an online cognitive training program, and has been used to improve cognitive function among persons with cognitive impairment based on principles of neuroplasticity.
tDCS-sham: tDCS devices used in the sham arm will be pre-programmed to deliver the same ramp up/down at the beginning/end of the 30-minute period as the active arm, except with no current otherwise delivered during the session.
|
|---|---|---|---|---|---|
|
Change in Everyday Cognition 2 (ECog2)
|
-0.40 score on a scale
Standard Deviation 0.59
|
-0.40 score on a scale
Standard Deviation 0.54
|
-0.20 score on a scale
Standard Deviation 0.64
|
-0.50 score on a scale
Standard Deviation 0.56
|
-0.50 score on a scale
Standard Deviation 0.65
|
SECONDARY outcome
Timeframe: Baseline, End of Intervention - EOI (Day 70), End of Study (EOS) (Day 160)Population: Participants with data collected.
The PROMIS-Cog is the PROMIS short form for the cognitive function domain and is a self-report, 8-item questionnaire targeting cognitive function in the past seven days. Scores range from 22.4 to 63.5. Higher scores are better.
Outcome measures
| Measure |
BrainHQ Active Comparator
n=61 Participants
5 sessions/week at 30 min/session
BrainHQ/Active Comparator Activity: BrainHQ platform provides a set of cognitive activities, like puzzles and games, that are cognitively stimulating and actively engage participants but do not continuously and adaptively challenge them. These activities are designed to be a face-valid, active comparison approach to cognitive therapy, thus participants are blinded, attention time is matched, and overall user experience is identical to the active arms.
|
BrainHQ
n=62 Participants
5 sessions/week at 30 min/session
BrainHQ: BrainHQ is an online cognitive training program, and has been used to improve cognitive function among persons with cognitive impairment based on principles of neuroplasticity.
|
BrainHQ + PASC CoRE
n=63 Participants
BrainHQ plus 9 group sessions at 1.5 hr/session and 3 individual sessions at 1 hr/session
BrainHQ: BrainHQ is an online cognitive training program, and has been used to improve cognitive function among persons with cognitive impairment based on principles of neuroplasticity.
PASC CoRE: PASC CoRE is a manualized, adaptable cognitive rehabilitation intervention adapted from Goal Management Training and other evidence based programs that improve attention and executive functions, among other cognitive domains.
|
Brain HQ + tDCS-active
n=55 Participants
2.0 mA stimulation delivered for 30 min during each BrainHQ session
BrainHQ: BrainHQ is an online cognitive training program, and has been used to improve cognitive function among persons with cognitive impairment based on principles of neuroplasticity.
tDCS-active: Transcranial direct current stimulation (tDCS) will use a device specifically for home-based use. This device delivers a weak electrical current of 2.0 mA passed through two electrodes placed on the scalp to target the dorsolateral prefrontal cortex region of the brain. The electrodes are single-use for each session and can be attached to a headset by snapping into place.
The device has a user-friendly interface and a large-button keypad, making it is easy to use at home.
|
Brain HQ + tDCS-sham
n=59 Participants
Inactive stimulation delivered for 30 min during each BrainHQ session
BrainHQ: BrainHQ is an online cognitive training program, and has been used to improve cognitive function among persons with cognitive impairment based on principles of neuroplasticity.
tDCS-sham: tDCS devices used in the sham arm will be pre-programmed to deliver the same ramp up/down at the beginning/end of the 30-minute period as the active arm, except with no current otherwise delivered during the session.
|
|---|---|---|---|---|---|
|
Change in PROMIS-cognitive Function - Short Form 8a (PROMIS-Cog) Total Score
Baseline to EOI
|
5.40 score on a scale
Standard Deviation 7.37
|
6.60 score on a scale
Standard Deviation 9.10
|
4.40 score on a scale
Standard Deviation 7.43
|
6.60 score on a scale
Standard Deviation 7.20
|
6.90 score on a scale
Standard Deviation 7.43
|
|
Change in PROMIS-cognitive Function - Short Form 8a (PROMIS-Cog) Total Score
Baseline to EOS
|
6.80 score on a scale
Standard Deviation 8.01
|
7.30 score on a scale
Standard Deviation 8.73
|
6.20 score on a scale
Standard Deviation 8.21
|
6.70 score on a scale
Standard Deviation 7.77
|
7.20 score on a scale
Standard Deviation 7.40
|
SECONDARY outcome
Timeframe: Baseline, End of Intervention - EOI (Day 70), End of Study (EOS) (Day 160)Population: Participants with data collected.
Trials #1-#5 report the total number correct across 5 trials. Trials #1-5 generate one total score, the individual scores for each trial are not analyzed. The Score for Trials #1-#5 range from 0-75; higher scores are better. Trial #8 reports the total number correct. Scores range from 0-15; higher scores are better. Trial #9 reports the total number correct recognition hits minus false positive. Scores range from 0-15; higher scores are better.
Outcome measures
| Measure |
BrainHQ Active Comparator
n=61 Participants
5 sessions/week at 30 min/session
BrainHQ/Active Comparator Activity: BrainHQ platform provides a set of cognitive activities, like puzzles and games, that are cognitively stimulating and actively engage participants but do not continuously and adaptively challenge them. These activities are designed to be a face-valid, active comparison approach to cognitive therapy, thus participants are blinded, attention time is matched, and overall user experience is identical to the active arms.
|
BrainHQ
n=62 Participants
5 sessions/week at 30 min/session
BrainHQ: BrainHQ is an online cognitive training program, and has been used to improve cognitive function among persons with cognitive impairment based on principles of neuroplasticity.
|
BrainHQ + PASC CoRE
n=63 Participants
BrainHQ plus 9 group sessions at 1.5 hr/session and 3 individual sessions at 1 hr/session
BrainHQ: BrainHQ is an online cognitive training program, and has been used to improve cognitive function among persons with cognitive impairment based on principles of neuroplasticity.
PASC CoRE: PASC CoRE is a manualized, adaptable cognitive rehabilitation intervention adapted from Goal Management Training and other evidence based programs that improve attention and executive functions, among other cognitive domains.
|
Brain HQ + tDCS-active
n=55 Participants
2.0 mA stimulation delivered for 30 min during each BrainHQ session
BrainHQ: BrainHQ is an online cognitive training program, and has been used to improve cognitive function among persons with cognitive impairment based on principles of neuroplasticity.
tDCS-active: Transcranial direct current stimulation (tDCS) will use a device specifically for home-based use. This device delivers a weak electrical current of 2.0 mA passed through two electrodes placed on the scalp to target the dorsolateral prefrontal cortex region of the brain. The electrodes are single-use for each session and can be attached to a headset by snapping into place.
The device has a user-friendly interface and a large-button keypad, making it is easy to use at home.
|
Brain HQ + tDCS-sham
n=59 Participants
Inactive stimulation delivered for 30 min during each BrainHQ session
BrainHQ: BrainHQ is an online cognitive training program, and has been used to improve cognitive function among persons with cognitive impairment based on principles of neuroplasticity.
tDCS-sham: tDCS devices used in the sham arm will be pre-programmed to deliver the same ramp up/down at the beginning/end of the 30-minute period as the active arm, except with no current otherwise delivered during the session.
|
|---|---|---|---|---|---|
|
Change on Auditory Verbal Learning Test
Baseline to EOI: trials 1-5
|
0.40 score on a scale
Standard Deviation 8.02
|
1.20 score on a scale
Standard Deviation 6.48
|
1.00 score on a scale
Standard Deviation 6.12
|
0.50 score on a scale
Standard Deviation 6.86
|
1.00 score on a scale
Standard Deviation 8.39
|
|
Change on Auditory Verbal Learning Test
Baseline to EOS: trials 1-5
|
5.20 score on a scale
Standard Deviation 8.25
|
6.10 score on a scale
Standard Deviation 7.47
|
6.00 score on a scale
Standard Deviation 6.32
|
5.60 score on a scale
Standard Deviation 7.53
|
4.80 score on a scale
Standard Deviation 7.95
|
|
Change on Auditory Verbal Learning Test
Baseline to EOI: trial 8
|
-0.20 score on a scale
Standard Deviation 2.89
|
-0.50 score on a scale
Standard Deviation 2.53
|
0.00 score on a scale
Standard Deviation 2.48
|
-0.30 score on a scale
Standard Deviation 3.21
|
-0.10 score on a scale
Standard Deviation 3.06
|
|
Change on Auditory Verbal Learning Test
Baseline to EOS: trial 8
|
1.70 score on a scale
Standard Deviation 2.56
|
1.30 score on a scale
Standard Deviation 2.53
|
1.60 score on a scale
Standard Deviation 2.12
|
1.10 score on a scale
Standard Deviation 2.40
|
1.60 score on a scale
Standard Deviation 2.22
|
|
Change on Auditory Verbal Learning Test
Baseline to EOI: trial 9
|
0.10 score on a scale
Standard Deviation 2.56
|
0.10 score on a scale
Standard Deviation 2.04
|
-0.40 score on a scale
Standard Deviation 2.40
|
0.00 score on a scale
Standard Deviation 1.93
|
0.50 score on a scale
Standard Deviation 3.52
|
|
Change on Auditory Verbal Learning Test
Baseline to EOS: trial 9
|
0.70 score on a scale
Standard Deviation 1.96
|
0.60 score on a scale
Standard Deviation 2.08
|
0.70 score on a scale
Standard Deviation 2.03
|
0.90 score on a scale
Standard Deviation 1.92
|
1.10 score on a scale
Standard Deviation 2.98
|
SECONDARY outcome
Timeframe: Baseline, End of Intervention - EOI (Day 70), End of Study (EOS) (Day 160)Population: Participants with data collected.
The Symbol Digit Modalities Test reports the total number correct on the test. Scores range from 0-110. Higher scores are better.
Outcome measures
| Measure |
BrainHQ Active Comparator
n=61 Participants
5 sessions/week at 30 min/session
BrainHQ/Active Comparator Activity: BrainHQ platform provides a set of cognitive activities, like puzzles and games, that are cognitively stimulating and actively engage participants but do not continuously and adaptively challenge them. These activities are designed to be a face-valid, active comparison approach to cognitive therapy, thus participants are blinded, attention time is matched, and overall user experience is identical to the active arms.
|
BrainHQ
n=62 Participants
5 sessions/week at 30 min/session
BrainHQ: BrainHQ is an online cognitive training program, and has been used to improve cognitive function among persons with cognitive impairment based on principles of neuroplasticity.
|
BrainHQ + PASC CoRE
n=63 Participants
BrainHQ plus 9 group sessions at 1.5 hr/session and 3 individual sessions at 1 hr/session
BrainHQ: BrainHQ is an online cognitive training program, and has been used to improve cognitive function among persons with cognitive impairment based on principles of neuroplasticity.
PASC CoRE: PASC CoRE is a manualized, adaptable cognitive rehabilitation intervention adapted from Goal Management Training and other evidence based programs that improve attention and executive functions, among other cognitive domains.
|
Brain HQ + tDCS-active
n=55 Participants
2.0 mA stimulation delivered for 30 min during each BrainHQ session
BrainHQ: BrainHQ is an online cognitive training program, and has been used to improve cognitive function among persons with cognitive impairment based on principles of neuroplasticity.
tDCS-active: Transcranial direct current stimulation (tDCS) will use a device specifically for home-based use. This device delivers a weak electrical current of 2.0 mA passed through two electrodes placed on the scalp to target the dorsolateral prefrontal cortex region of the brain. The electrodes are single-use for each session and can be attached to a headset by snapping into place.
The device has a user-friendly interface and a large-button keypad, making it is easy to use at home.
|
Brain HQ + tDCS-sham
n=59 Participants
Inactive stimulation delivered for 30 min during each BrainHQ session
BrainHQ: BrainHQ is an online cognitive training program, and has been used to improve cognitive function among persons with cognitive impairment based on principles of neuroplasticity.
tDCS-sham: tDCS devices used in the sham arm will be pre-programmed to deliver the same ramp up/down at the beginning/end of the 30-minute period as the active arm, except with no current otherwise delivered during the session.
|
|---|---|---|---|---|---|
|
Change on Symbol Digit Modalities Test
Baseline to EOI
|
4.20 correct items
Standard Deviation 7.50
|
3.20 correct items
Standard Deviation 7.55
|
3.40 correct items
Standard Deviation 7.26
|
5.20 correct items
Standard Deviation 8.84
|
5.40 correct items
Standard Deviation 9.08
|
|
Change on Symbol Digit Modalities Test
Baseline to EOS
|
6.40 correct items
Standard Deviation 8.01
|
3.80 correct items
Standard Deviation 7.90
|
5.00 correct items
Standard Deviation 8.03
|
5.70 correct items
Standard Deviation 8.60
|
6.80 correct items
Standard Deviation 9.61
|
SECONDARY outcome
Timeframe: Baseline, End of Intervention - EOI (Day 70), End of Study (EOS) (Day 160)Population: Participants with data collected.
The Verbal Fluency Semantic reports the total number correct. Scores range from 0-110. Higher scores are better.
Outcome measures
| Measure |
BrainHQ Active Comparator
n=61 Participants
5 sessions/week at 30 min/session
BrainHQ/Active Comparator Activity: BrainHQ platform provides a set of cognitive activities, like puzzles and games, that are cognitively stimulating and actively engage participants but do not continuously and adaptively challenge them. These activities are designed to be a face-valid, active comparison approach to cognitive therapy, thus participants are blinded, attention time is matched, and overall user experience is identical to the active arms.
|
BrainHQ
n=62 Participants
5 sessions/week at 30 min/session
BrainHQ: BrainHQ is an online cognitive training program, and has been used to improve cognitive function among persons with cognitive impairment based on principles of neuroplasticity.
|
BrainHQ + PASC CoRE
n=63 Participants
BrainHQ plus 9 group sessions at 1.5 hr/session and 3 individual sessions at 1 hr/session
BrainHQ: BrainHQ is an online cognitive training program, and has been used to improve cognitive function among persons with cognitive impairment based on principles of neuroplasticity.
PASC CoRE: PASC CoRE is a manualized, adaptable cognitive rehabilitation intervention adapted from Goal Management Training and other evidence based programs that improve attention and executive functions, among other cognitive domains.
|
Brain HQ + tDCS-active
n=55 Participants
2.0 mA stimulation delivered for 30 min during each BrainHQ session
BrainHQ: BrainHQ is an online cognitive training program, and has been used to improve cognitive function among persons with cognitive impairment based on principles of neuroplasticity.
tDCS-active: Transcranial direct current stimulation (tDCS) will use a device specifically for home-based use. This device delivers a weak electrical current of 2.0 mA passed through two electrodes placed on the scalp to target the dorsolateral prefrontal cortex region of the brain. The electrodes are single-use for each session and can be attached to a headset by snapping into place.
The device has a user-friendly interface and a large-button keypad, making it is easy to use at home.
|
Brain HQ + tDCS-sham
n=59 Participants
Inactive stimulation delivered for 30 min during each BrainHQ session
BrainHQ: BrainHQ is an online cognitive training program, and has been used to improve cognitive function among persons with cognitive impairment based on principles of neuroplasticity.
tDCS-sham: tDCS devices used in the sham arm will be pre-programmed to deliver the same ramp up/down at the beginning/end of the 30-minute period as the active arm, except with no current otherwise delivered during the session.
|
|---|---|---|---|---|---|
|
Change in Verbal Fluency
Baseline to EOI: Semantic
|
0.50 correct items
Standard Deviation 3.79
|
0.90 correct items
Standard Deviation 4.14
|
0.90 correct items
Standard Deviation 4.61
|
1.71 correct items
Standard Deviation 4.56
|
1.60 correct items
Standard Deviation 4.15
|
|
Change in Verbal Fluency
Baseline to EOS: Semantic
|
0.90 correct items
Standard Deviation 3.79
|
.010 correct items
Standard Deviation 4.34
|
2.30 correct items
Standard Deviation 5.53
|
2.20 correct items
Standard Deviation 4.79
|
1.40 correct items
Standard Deviation 4.57
|
|
Change in Verbal Fluency
Baseline to EOI: Lexical
|
0.20 correct items
Standard Deviation 3.33
|
1.00 correct items
Standard Deviation 3.49
|
0.30 correct items
Standard Deviation 3.78
|
0.60 correct items
Standard Deviation 3.39
|
1.70 correct items
Standard Deviation 3.25
|
|
Change in Verbal Fluency
Baseline to EOS: Lexical
|
0.20 correct items
Standard Deviation 3.23
|
1.30 correct items
Standard Deviation 3.43
|
0.90 correct items
Standard Deviation 3.67
|
1.10 correct items
Standard Deviation 3.73
|
1.30 correct items
Standard Deviation 3.85
|
SECONDARY outcome
Timeframe: Baseline, End of Intervention - EOI (Day 70), End of Study (EOS) (Day 160)Population: Participants with data collected.
Outcome measures
| Measure |
BrainHQ Active Comparator
n=61 Participants
5 sessions/week at 30 min/session
BrainHQ/Active Comparator Activity: BrainHQ platform provides a set of cognitive activities, like puzzles and games, that are cognitively stimulating and actively engage participants but do not continuously and adaptively challenge them. These activities are designed to be a face-valid, active comparison approach to cognitive therapy, thus participants are blinded, attention time is matched, and overall user experience is identical to the active arms.
|
BrainHQ
n=62 Participants
5 sessions/week at 30 min/session
BrainHQ: BrainHQ is an online cognitive training program, and has been used to improve cognitive function among persons with cognitive impairment based on principles of neuroplasticity.
|
BrainHQ + PASC CoRE
n=63 Participants
BrainHQ plus 9 group sessions at 1.5 hr/session and 3 individual sessions at 1 hr/session
BrainHQ: BrainHQ is an online cognitive training program, and has been used to improve cognitive function among persons with cognitive impairment based on principles of neuroplasticity.
PASC CoRE: PASC CoRE is a manualized, adaptable cognitive rehabilitation intervention adapted from Goal Management Training and other evidence based programs that improve attention and executive functions, among other cognitive domains.
|
Brain HQ + tDCS-active
n=55 Participants
2.0 mA stimulation delivered for 30 min during each BrainHQ session
BrainHQ: BrainHQ is an online cognitive training program, and has been used to improve cognitive function among persons with cognitive impairment based on principles of neuroplasticity.
tDCS-active: Transcranial direct current stimulation (tDCS) will use a device specifically for home-based use. This device delivers a weak electrical current of 2.0 mA passed through two electrodes placed on the scalp to target the dorsolateral prefrontal cortex region of the brain. The electrodes are single-use for each session and can be attached to a headset by snapping into place.
The device has a user-friendly interface and a large-button keypad, making it is easy to use at home.
|
Brain HQ + tDCS-sham
n=59 Participants
Inactive stimulation delivered for 30 min during each BrainHQ session
BrainHQ: BrainHQ is an online cognitive training program, and has been used to improve cognitive function among persons with cognitive impairment based on principles of neuroplasticity.
tDCS-sham: tDCS devices used in the sham arm will be pre-programmed to deliver the same ramp up/down at the beginning/end of the 30-minute period as the active arm, except with no current otherwise delivered during the session.
|
|---|---|---|---|---|---|
|
Change in Total Time to Complete the Digit Vigilance Test
Baseline to EOI
|
-16.1 seconds
Standard Deviation 65.41
|
-31.7 seconds
Standard Deviation 79.29
|
-19.20 seconds
Standard Deviation 72.72
|
-37.10 seconds
Standard Deviation 71.42
|
-19.20 seconds
Standard Deviation 71.57
|
|
Change in Total Time to Complete the Digit Vigilance Test
Baseline to EOS
|
-13.40 seconds
Standard Deviation 74.81
|
-27.10 seconds
Standard Deviation 69.19
|
-15.70 seconds
Standard Deviation 92.48
|
-23.40 seconds
Standard Deviation 78.53
|
-17.80 seconds
Standard Deviation 63.57
|
SECONDARY outcome
Timeframe: Baseline, End of Intervention - EOI (Day 70), End of Study (EOS) (Day 160)Population: Participants with data collected.
The Flanker Inhibitory Control and Attention Test Computed Score ranges from 0-10. Higher scores are better.
Outcome measures
| Measure |
BrainHQ Active Comparator
n=58 Participants
5 sessions/week at 30 min/session
BrainHQ/Active Comparator Activity: BrainHQ platform provides a set of cognitive activities, like puzzles and games, that are cognitively stimulating and actively engage participants but do not continuously and adaptively challenge them. These activities are designed to be a face-valid, active comparison approach to cognitive therapy, thus participants are blinded, attention time is matched, and overall user experience is identical to the active arms.
|
BrainHQ
n=59 Participants
5 sessions/week at 30 min/session
BrainHQ: BrainHQ is an online cognitive training program, and has been used to improve cognitive function among persons with cognitive impairment based on principles of neuroplasticity.
|
BrainHQ + PASC CoRE
n=61 Participants
BrainHQ plus 9 group sessions at 1.5 hr/session and 3 individual sessions at 1 hr/session
BrainHQ: BrainHQ is an online cognitive training program, and has been used to improve cognitive function among persons with cognitive impairment based on principles of neuroplasticity.
PASC CoRE: PASC CoRE is a manualized, adaptable cognitive rehabilitation intervention adapted from Goal Management Training and other evidence based programs that improve attention and executive functions, among other cognitive domains.
|
Brain HQ + tDCS-active
n=51 Participants
2.0 mA stimulation delivered for 30 min during each BrainHQ session
BrainHQ: BrainHQ is an online cognitive training program, and has been used to improve cognitive function among persons with cognitive impairment based on principles of neuroplasticity.
tDCS-active: Transcranial direct current stimulation (tDCS) will use a device specifically for home-based use. This device delivers a weak electrical current of 2.0 mA passed through two electrodes placed on the scalp to target the dorsolateral prefrontal cortex region of the brain. The electrodes are single-use for each session and can be attached to a headset by snapping into place.
The device has a user-friendly interface and a large-button keypad, making it is easy to use at home.
|
Brain HQ + tDCS-sham
n=55 Participants
Inactive stimulation delivered for 30 min during each BrainHQ session
BrainHQ: BrainHQ is an online cognitive training program, and has been used to improve cognitive function among persons with cognitive impairment based on principles of neuroplasticity.
tDCS-sham: tDCS devices used in the sham arm will be pre-programmed to deliver the same ramp up/down at the beginning/end of the 30-minute period as the active arm, except with no current otherwise delivered during the session.
|
|---|---|---|---|---|---|
|
Change on NIH Toolbox Flanker Inhibitory Control and Attention Test
Baseline to EOS
|
0.50 score on a scale
Standard Deviation 0.89
|
0.40 score on a scale
Standard Deviation 0.67
|
0.50 score on a scale
Standard Deviation 0.65
|
0.50 score on a scale
Standard Deviation 0.91
|
0.60 score on a scale
Standard Deviation 0.83
|
|
Change on NIH Toolbox Flanker Inhibitory Control and Attention Test
Baseline to EOI
|
0.40 score on a scale
Standard Deviation 0.84
|
0.50 score on a scale
Standard Deviation 0.77
|
0.40 score on a scale
Standard Deviation 0.85
|
0.40 score on a scale
Standard Deviation 0.99
|
0.60 score on a scale
Standard Deviation 0.82
|
SECONDARY outcome
Timeframe: Baseline, End of Intervention - EOI (Day 70), End of Study (EOS) (Day 160)Population: Participants with data collected.
CogState Detection Score is the mean of log10 transformed reaction times. Lower values are better.
Outcome measures
| Measure |
BrainHQ Active Comparator
n=48 Participants
5 sessions/week at 30 min/session
BrainHQ/Active Comparator Activity: BrainHQ platform provides a set of cognitive activities, like puzzles and games, that are cognitively stimulating and actively engage participants but do not continuously and adaptively challenge them. These activities are designed to be a face-valid, active comparison approach to cognitive therapy, thus participants are blinded, attention time is matched, and overall user experience is identical to the active arms.
|
BrainHQ
n=44 Participants
5 sessions/week at 30 min/session
BrainHQ: BrainHQ is an online cognitive training program, and has been used to improve cognitive function among persons with cognitive impairment based on principles of neuroplasticity.
|
BrainHQ + PASC CoRE
n=44 Participants
BrainHQ plus 9 group sessions at 1.5 hr/session and 3 individual sessions at 1 hr/session
BrainHQ: BrainHQ is an online cognitive training program, and has been used to improve cognitive function among persons with cognitive impairment based on principles of neuroplasticity.
PASC CoRE: PASC CoRE is a manualized, adaptable cognitive rehabilitation intervention adapted from Goal Management Training and other evidence based programs that improve attention and executive functions, among other cognitive domains.
|
Brain HQ + tDCS-active
n=40 Participants
2.0 mA stimulation delivered for 30 min during each BrainHQ session
BrainHQ: BrainHQ is an online cognitive training program, and has been used to improve cognitive function among persons with cognitive impairment based on principles of neuroplasticity.
tDCS-active: Transcranial direct current stimulation (tDCS) will use a device specifically for home-based use. This device delivers a weak electrical current of 2.0 mA passed through two electrodes placed on the scalp to target the dorsolateral prefrontal cortex region of the brain. The electrodes are single-use for each session and can be attached to a headset by snapping into place.
The device has a user-friendly interface and a large-button keypad, making it is easy to use at home.
|
Brain HQ + tDCS-sham
n=45 Participants
Inactive stimulation delivered for 30 min during each BrainHQ session
BrainHQ: BrainHQ is an online cognitive training program, and has been used to improve cognitive function among persons with cognitive impairment based on principles of neuroplasticity.
tDCS-sham: tDCS devices used in the sham arm will be pre-programmed to deliver the same ramp up/down at the beginning/end of the 30-minute period as the active arm, except with no current otherwise delivered during the session.
|
|---|---|---|---|---|---|
|
Change in CogState Detection Score
Baseline to EOI
|
0.00 log(ms)
Standard Deviation 0.10
|
0.00 log(ms)
Standard Deviation 0.08
|
-0.10 log(ms)
Standard Deviation 0.10
|
0.00 log(ms)
Standard Deviation 0.10
|
-0.10 log(ms)
Standard Deviation 0.11
|
|
Change in CogState Detection Score
Baseline to EOS
|
0.00 log(ms)
Standard Deviation 0.09
|
0.00 log(ms)
Standard Deviation 0.07
|
-0.10 log(ms)
Standard Deviation 0.12
|
0.00 log(ms)
Standard Deviation 0.09
|
0.00 log(ms)
Standard Deviation 0.12
|
SECONDARY outcome
Timeframe: Baseline, End of Intervention - EOI (Day 70), End of Study (EOS) (Day 160)Population: Participants with data collected.
CogState Identification Score is the mean of log10 transformed reaction times for correct responses. Lower values are better.
Outcome measures
| Measure |
BrainHQ Active Comparator
n=50 Participants
5 sessions/week at 30 min/session
BrainHQ/Active Comparator Activity: BrainHQ platform provides a set of cognitive activities, like puzzles and games, that are cognitively stimulating and actively engage participants but do not continuously and adaptively challenge them. These activities are designed to be a face-valid, active comparison approach to cognitive therapy, thus participants are blinded, attention time is matched, and overall user experience is identical to the active arms.
|
BrainHQ
n=44 Participants
5 sessions/week at 30 min/session
BrainHQ: BrainHQ is an online cognitive training program, and has been used to improve cognitive function among persons with cognitive impairment based on principles of neuroplasticity.
|
BrainHQ + PASC CoRE
n=49 Participants
BrainHQ plus 9 group sessions at 1.5 hr/session and 3 individual sessions at 1 hr/session
BrainHQ: BrainHQ is an online cognitive training program, and has been used to improve cognitive function among persons with cognitive impairment based on principles of neuroplasticity.
PASC CoRE: PASC CoRE is a manualized, adaptable cognitive rehabilitation intervention adapted from Goal Management Training and other evidence based programs that improve attention and executive functions, among other cognitive domains.
|
Brain HQ + tDCS-active
n=42 Participants
2.0 mA stimulation delivered for 30 min during each BrainHQ session
BrainHQ: BrainHQ is an online cognitive training program, and has been used to improve cognitive function among persons with cognitive impairment based on principles of neuroplasticity.
tDCS-active: Transcranial direct current stimulation (tDCS) will use a device specifically for home-based use. This device delivers a weak electrical current of 2.0 mA passed through two electrodes placed on the scalp to target the dorsolateral prefrontal cortex region of the brain. The electrodes are single-use for each session and can be attached to a headset by snapping into place.
The device has a user-friendly interface and a large-button keypad, making it is easy to use at home.
|
Brain HQ + tDCS-sham
n=46 Participants
Inactive stimulation delivered for 30 min during each BrainHQ session
BrainHQ: BrainHQ is an online cognitive training program, and has been used to improve cognitive function among persons with cognitive impairment based on principles of neuroplasticity.
tDCS-sham: tDCS devices used in the sham arm will be pre-programmed to deliver the same ramp up/down at the beginning/end of the 30-minute period as the active arm, except with no current otherwise delivered during the session.
|
|---|---|---|---|---|---|
|
Change in CogState Identification Score
Baseline to EOI
|
0.00 log(ms)
Standard Deviation 0.09
|
0.00 log(ms)
Standard Deviation 0.07
|
-0.10 log(ms)
Standard Deviation 0.11
|
-0.10 log(ms)
Standard Deviation 0.11
|
-0.10 log(ms)
Standard Deviation 0.10
|
|
Change in CogState Identification Score
Baseline to EOS
|
0.00 log(ms)
Standard Deviation 0.07
|
0.00 log(ms)
Standard Deviation 0.08
|
-0.10 log(ms)
Standard Deviation 0.10
|
-0.10 log(ms)
Standard Deviation 0.09
|
0.00 log(ms)
Standard Deviation 0.09
|
SECONDARY outcome
Timeframe: Baseline, End of Intervention - EOI (Day 70), End of Study (EOS) (Day 160)Population: Participants with data collected.
CogState One Back Primary Score is the arcsine transformation of the square root of the proportion of correct responses. The scale ranges from 0 to π/2. Higher scores are better.
Outcome measures
| Measure |
BrainHQ Active Comparator
n=50 Participants
5 sessions/week at 30 min/session
BrainHQ/Active Comparator Activity: BrainHQ platform provides a set of cognitive activities, like puzzles and games, that are cognitively stimulating and actively engage participants but do not continuously and adaptively challenge them. These activities are designed to be a face-valid, active comparison approach to cognitive therapy, thus participants are blinded, attention time is matched, and overall user experience is identical to the active arms.
|
BrainHQ
n=44 Participants
5 sessions/week at 30 min/session
BrainHQ: BrainHQ is an online cognitive training program, and has been used to improve cognitive function among persons with cognitive impairment based on principles of neuroplasticity.
|
BrainHQ + PASC CoRE
n=49 Participants
BrainHQ plus 9 group sessions at 1.5 hr/session and 3 individual sessions at 1 hr/session
BrainHQ: BrainHQ is an online cognitive training program, and has been used to improve cognitive function among persons with cognitive impairment based on principles of neuroplasticity.
PASC CoRE: PASC CoRE is a manualized, adaptable cognitive rehabilitation intervention adapted from Goal Management Training and other evidence based programs that improve attention and executive functions, among other cognitive domains.
|
Brain HQ + tDCS-active
n=42 Participants
2.0 mA stimulation delivered for 30 min during each BrainHQ session
BrainHQ: BrainHQ is an online cognitive training program, and has been used to improve cognitive function among persons with cognitive impairment based on principles of neuroplasticity.
tDCS-active: Transcranial direct current stimulation (tDCS) will use a device specifically for home-based use. This device delivers a weak electrical current of 2.0 mA passed through two electrodes placed on the scalp to target the dorsolateral prefrontal cortex region of the brain. The electrodes are single-use for each session and can be attached to a headset by snapping into place.
The device has a user-friendly interface and a large-button keypad, making it is easy to use at home.
|
Brain HQ + tDCS-sham
n=46 Participants
Inactive stimulation delivered for 30 min during each BrainHQ session
BrainHQ: BrainHQ is an online cognitive training program, and has been used to improve cognitive function among persons with cognitive impairment based on principles of neuroplasticity.
tDCS-sham: tDCS devices used in the sham arm will be pre-programmed to deliver the same ramp up/down at the beginning/end of the 30-minute period as the active arm, except with no current otherwise delivered during the session.
|
|---|---|---|---|---|---|
|
Change in CogState One Back Primary Score
Baseline to EOI
|
0.00 score on a scale
Standard Deviation 0.18
|
0.00 score on a scale
Standard Deviation 0.15
|
0.00 score on a scale
Standard Deviation 0.16
|
0.00 score on a scale
Standard Deviation 0.19
|
0.10 score on a scale
Standard Deviation 0.19
|
|
Change in CogState One Back Primary Score
Baseline to EOS
|
0.00 score on a scale
Standard Deviation 0.16
|
0.00 score on a scale
Standard Deviation 0.18
|
0.00 score on a scale
Standard Deviation 0.14
|
0.00 score on a scale
Standard Deviation 0.18
|
0.00 score on a scale
Standard Deviation 0.20
|
SECONDARY outcome
Timeframe: Baseline, EOS (Day 160)Population: Participants with data collected.
Everyday Cognition 2 (ECog2) is a self-report, 41-item questionnaire used to measure the participant's simple reaction time; respond when X happens and Choice reaction time; respond only if X happens.
Outcome measures
| Measure |
BrainHQ Active Comparator
n=59 Participants
5 sessions/week at 30 min/session
BrainHQ/Active Comparator Activity: BrainHQ platform provides a set of cognitive activities, like puzzles and games, that are cognitively stimulating and actively engage participants but do not continuously and adaptively challenge them. These activities are designed to be a face-valid, active comparison approach to cognitive therapy, thus participants are blinded, attention time is matched, and overall user experience is identical to the active arms.
|
BrainHQ
n=62 Participants
5 sessions/week at 30 min/session
BrainHQ: BrainHQ is an online cognitive training program, and has been used to improve cognitive function among persons with cognitive impairment based on principles of neuroplasticity.
|
BrainHQ + PASC CoRE
n=62 Participants
BrainHQ plus 9 group sessions at 1.5 hr/session and 3 individual sessions at 1 hr/session
BrainHQ: BrainHQ is an online cognitive training program, and has been used to improve cognitive function among persons with cognitive impairment based on principles of neuroplasticity.
PASC CoRE: PASC CoRE is a manualized, adaptable cognitive rehabilitation intervention adapted from Goal Management Training and other evidence based programs that improve attention and executive functions, among other cognitive domains.
|
Brain HQ + tDCS-active
n=54 Participants
2.0 mA stimulation delivered for 30 min during each BrainHQ session
BrainHQ: BrainHQ is an online cognitive training program, and has been used to improve cognitive function among persons with cognitive impairment based on principles of neuroplasticity.
tDCS-active: Transcranial direct current stimulation (tDCS) will use a device specifically for home-based use. This device delivers a weak electrical current of 2.0 mA passed through two electrodes placed on the scalp to target the dorsolateral prefrontal cortex region of the brain. The electrodes are single-use for each session and can be attached to a headset by snapping into place.
The device has a user-friendly interface and a large-button keypad, making it is easy to use at home.
|
Brain HQ + tDCS-sham
n=58 Participants
Inactive stimulation delivered for 30 min during each BrainHQ session
BrainHQ: BrainHQ is an online cognitive training program, and has been used to improve cognitive function among persons with cognitive impairment based on principles of neuroplasticity.
tDCS-sham: tDCS devices used in the sham arm will be pre-programmed to deliver the same ramp up/down at the beginning/end of the 30-minute period as the active arm, except with no current otherwise delivered during the session.
|
|---|---|---|---|---|---|
|
Change in Everyday Cognition 2 (ECog2)
|
-0.50 score on a scale
Standard Deviation 0.65
|
-0.50 score on a scale
Standard Deviation 0.59
|
-0.40 score on a scale
Standard Deviation 0.68
|
-0.60 score on a scale
Standard Deviation 0.64
|
-0.50 score on a scale
Standard Deviation 0.71
|
SECONDARY outcome
Timeframe: Baseline to EOS (Day 160)Population: Participants experiencing one or more SAE and/or UADE.
An SAE or serious suspected adverse reaction (SAR) or serious adverse reaction an AE that results in any of the following serious outcomes: Death, life-threatening, persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions, inpatient hospitalization or prolongation of existing hospitalization, congenital abnormality or birth defect, important medical event that may not result in one of the above outcomes, but may jeopardize the health of the study participant or require medical or surgical intervention to prevent one of the above outcomes from occurring. A UADE is any serious adverse effect, problem, or death caused by or associated with a device if that effect was not previously identified in the investigational plan or application (including a supplementary plan or application), or any other unanticipated serious problem associated with a device that relates to the rights, safety, or welfare of subjects.
Outcome measures
| Measure |
BrainHQ Active Comparator
n=3 Participants
5 sessions/week at 30 min/session
BrainHQ/Active Comparator Activity: BrainHQ platform provides a set of cognitive activities, like puzzles and games, that are cognitively stimulating and actively engage participants but do not continuously and adaptively challenge them. These activities are designed to be a face-valid, active comparison approach to cognitive therapy, thus participants are blinded, attention time is matched, and overall user experience is identical to the active arms.
|
BrainHQ
n=2 Participants
5 sessions/week at 30 min/session
BrainHQ: BrainHQ is an online cognitive training program, and has been used to improve cognitive function among persons with cognitive impairment based on principles of neuroplasticity.
|
BrainHQ + PASC CoRE
n=3 Participants
BrainHQ plus 9 group sessions at 1.5 hr/session and 3 individual sessions at 1 hr/session
BrainHQ: BrainHQ is an online cognitive training program, and has been used to improve cognitive function among persons with cognitive impairment based on principles of neuroplasticity.
PASC CoRE: PASC CoRE is a manualized, adaptable cognitive rehabilitation intervention adapted from Goal Management Training and other evidence based programs that improve attention and executive functions, among other cognitive domains.
|
Brain HQ + tDCS-active
2.0 mA stimulation delivered for 30 min during each BrainHQ session
BrainHQ: BrainHQ is an online cognitive training program, and has been used to improve cognitive function among persons with cognitive impairment based on principles of neuroplasticity.
tDCS-active: Transcranial direct current stimulation (tDCS) will use a device specifically for home-based use. This device delivers a weak electrical current of 2.0 mA passed through two electrodes placed on the scalp to target the dorsolateral prefrontal cortex region of the brain. The electrodes are single-use for each session and can be attached to a headset by snapping into place.
The device has a user-friendly interface and a large-button keypad, making it is easy to use at home.
|
Brain HQ + tDCS-sham
n=4 Participants
Inactive stimulation delivered for 30 min during each BrainHQ session
BrainHQ: BrainHQ is an online cognitive training program, and has been used to improve cognitive function among persons with cognitive impairment based on principles of neuroplasticity.
tDCS-sham: tDCS devices used in the sham arm will be pre-programmed to deliver the same ramp up/down at the beginning/end of the 30-minute period as the active arm, except with no current otherwise delivered during the session.
|
|---|---|---|---|---|---|
|
Total Number of Serious Adverse Events (SAEs) or Unanticipated Adverse Device Effects (UADEs)
SAEs
|
7 events
|
2 events
|
5 events
|
—
|
5 events
|
|
Total Number of Serious Adverse Events (SAEs) or Unanticipated Adverse Device Effects (UADEs)
UADEs
|
0 events
|
0 events
|
0 events
|
—
|
0 events
|
Adverse Events
BrainHQ Active Comparator
Serious events: 3 serious events
Other events: 0 other events
Deaths: 0 deaths
BrainHQ
Serious events: 2 serious events
Other events: 3 other events
Deaths: 0 deaths
BrainHQ + PASC CoRE
Serious events: 3 serious events
Other events: 0 other events
Deaths: 0 deaths
Brain HQ + tDCS-active
Serious events: 0 serious events
Other events: 7 other events
Deaths: 0 deaths
Brain HQ + tDCS-sham
Serious events: 4 serious events
Other events: 5 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
BrainHQ Active Comparator
n=63 participants at risk
5 sessions/week at 30 min/session
BrainHQ/Active Comparator Activity: BrainHQ platform provides a set of cognitive activities, like puzzles and games, that are cognitively stimulating and actively engage participants but do not continuously and adaptively challenge them. These activities are designed to be a face-valid, active comparison approach to cognitive therapy, thus participants are blinded, attention time is matched, and overall user experience is identical to the active arms.
|
BrainHQ
n=66 participants at risk
5 sessions/week at 30 min/session
BrainHQ: BrainHQ is an online cognitive training program, and has been used to improve cognitive function among persons with cognitive impairment based on principles of neuroplasticity.
|
BrainHQ + PASC CoRE
n=66 participants at risk
BrainHQ plus 9 group sessions at 1.5 hr/session and 3 individual sessions at 1 hr/session
BrainHQ: BrainHQ is an online cognitive training program, and has been used to improve cognitive function among persons with cognitive impairment based on principles of neuroplasticity.
PASC CoRE: PASC CoRE is a manualized, adaptable cognitive rehabilitation intervention adapted from Goal Management Training and other evidence based programs that improve attention and executive functions, among other cognitive domains.
|
Brain HQ + tDCS-active
n=62 participants at risk
2.0 mA stimulation delivered for 30 min during each BrainHQ session
BrainHQ: BrainHQ is an online cognitive training program, and has been used to improve cognitive function among persons with cognitive impairment based on principles of neuroplasticity.
tDCS-active: Transcranial direct current stimulation (tDCS) will use a device specifically for home-based use. This device delivers a weak electrical current of 2.0 mA passed through two electrodes placed on the scalp to target the dorsolateral prefrontal cortex region of the brain. The electrodes are single-use for each session and can be attached to a headset by snapping into place.
The device has a user-friendly interface and a large-button keypad, making it is easy to use at home.
|
Brain HQ + tDCS-sham
n=63 participants at risk
Inactive stimulation delivered for 30 min during each BrainHQ session
BrainHQ: BrainHQ is an online cognitive training program, and has been used to improve cognitive function among persons with cognitive impairment based on principles of neuroplasticity.
tDCS-sham: tDCS devices used in the sham arm will be pre-programmed to deliver the same ramp up/down at the beginning/end of the 30-minute period as the active arm, except with no current otherwise delivered during the session.
|
|---|---|---|---|---|---|
|
Injury, Poisoning and Procedural Complications
Animal bite
|
0.00%
0/63 • Adverse events were collected from first invasive procedure (during screening) until EOS (Day 160).
|
0.00%
0/66 • Adverse events were collected from first invasive procedure (during screening) until EOS (Day 160).
|
0.00%
0/66 • Adverse events were collected from first invasive procedure (during screening) until EOS (Day 160).
|
0.00%
0/62 • Adverse events were collected from first invasive procedure (during screening) until EOS (Day 160).
|
1.6%
1/63 • Adverse events were collected from first invasive procedure (during screening) until EOS (Day 160).
|
|
Cardiac Disorders
Atrial fibrillation
|
0.00%
0/63 • Adverse events were collected from first invasive procedure (during screening) until EOS (Day 160).
|
0.00%
0/66 • Adverse events were collected from first invasive procedure (during screening) until EOS (Day 160).
|
0.00%
0/66 • Adverse events were collected from first invasive procedure (during screening) until EOS (Day 160).
|
0.00%
0/62 • Adverse events were collected from first invasive procedure (during screening) until EOS (Day 160).
|
1.6%
1/63 • Adverse events were collected from first invasive procedure (during screening) until EOS (Day 160).
|
|
Nervous System Disorders
Autonomic nervous system imbalance
|
0.00%
0/63 • Adverse events were collected from first invasive procedure (during screening) until EOS (Day 160).
|
0.00%
0/66 • Adverse events were collected from first invasive procedure (during screening) until EOS (Day 160).
|
0.00%
0/66 • Adverse events were collected from first invasive procedure (during screening) until EOS (Day 160).
|
0.00%
0/62 • Adverse events were collected from first invasive procedure (during screening) until EOS (Day 160).
|
1.6%
1/63 • Adverse events were collected from first invasive procedure (during screening) until EOS (Day 160).
|
|
Infections and Infestations
Bacteraemia
|
0.00%
0/63 • Adverse events were collected from first invasive procedure (during screening) until EOS (Day 160).
|
0.00%
0/66 • Adverse events were collected from first invasive procedure (during screening) until EOS (Day 160).
|
1.5%
1/66 • Adverse events were collected from first invasive procedure (during screening) until EOS (Day 160).
|
0.00%
0/62 • Adverse events were collected from first invasive procedure (during screening) until EOS (Day 160).
|
0.00%
0/63 • Adverse events were collected from first invasive procedure (during screening) until EOS (Day 160).
|
|
Neoplasms Benign, Malignant and Unspecified (Including Cysts and Polyps)
Breast cancer
|
0.00%
0/63 • Adverse events were collected from first invasive procedure (during screening) until EOS (Day 160).
|
0.00%
0/66 • Adverse events were collected from first invasive procedure (during screening) until EOS (Day 160).
|
0.00%
0/66 • Adverse events were collected from first invasive procedure (during screening) until EOS (Day 160).
|
0.00%
0/62 • Adverse events were collected from first invasive procedure (during screening) until EOS (Day 160).
|
1.6%
1/63 • Adverse events were collected from first invasive procedure (during screening) until EOS (Day 160).
|
|
Respiratory, Thoracic and Mediastinal Disorders
Bronchial secretion retention
|
1.6%
1/63 • Adverse events were collected from first invasive procedure (during screening) until EOS (Day 160).
|
0.00%
0/66 • Adverse events were collected from first invasive procedure (during screening) until EOS (Day 160).
|
0.00%
0/66 • Adverse events were collected from first invasive procedure (during screening) until EOS (Day 160).
|
0.00%
0/62 • Adverse events were collected from first invasive procedure (during screening) until EOS (Day 160).
|
0.00%
0/63 • Adverse events were collected from first invasive procedure (during screening) until EOS (Day 160).
|
|
Infections and Infestations
COVID-19
|
1.6%
1/63 • Adverse events were collected from first invasive procedure (during screening) until EOS (Day 160).
|
0.00%
0/66 • Adverse events were collected from first invasive procedure (during screening) until EOS (Day 160).
|
0.00%
0/66 • Adverse events were collected from first invasive procedure (during screening) until EOS (Day 160).
|
0.00%
0/62 • Adverse events were collected from first invasive procedure (during screening) until EOS (Day 160).
|
0.00%
0/63 • Adverse events were collected from first invasive procedure (during screening) until EOS (Day 160).
|
|
Vascular Disorders
Cerebral aneurysm perforation
|
0.00%
0/63 • Adverse events were collected from first invasive procedure (during screening) until EOS (Day 160).
|
1.5%
1/66 • Adverse events were collected from first invasive procedure (during screening) until EOS (Day 160).
|
0.00%
0/66 • Adverse events were collected from first invasive procedure (during screening) until EOS (Day 160).
|
0.00%
0/62 • Adverse events were collected from first invasive procedure (during screening) until EOS (Day 160).
|
0.00%
0/63 • Adverse events were collected from first invasive procedure (during screening) until EOS (Day 160).
|
|
Nervous System Disorders
Concussion
|
0.00%
0/63 • Adverse events were collected from first invasive procedure (during screening) until EOS (Day 160).
|
0.00%
0/66 • Adverse events were collected from first invasive procedure (during screening) until EOS (Day 160).
|
1.5%
1/66 • Adverse events were collected from first invasive procedure (during screening) until EOS (Day 160).
|
0.00%
0/62 • Adverse events were collected from first invasive procedure (during screening) until EOS (Day 160).
|
0.00%
0/63 • Adverse events were collected from first invasive procedure (during screening) until EOS (Day 160).
|
|
Metabolism and Nutrition Disorders
Dehydration
|
1.6%
1/63 • Adverse events were collected from first invasive procedure (during screening) until EOS (Day 160).
|
0.00%
0/66 • Adverse events were collected from first invasive procedure (during screening) until EOS (Day 160).
|
0.00%
0/66 • Adverse events were collected from first invasive procedure (during screening) until EOS (Day 160).
|
0.00%
0/62 • Adverse events were collected from first invasive procedure (during screening) until EOS (Day 160).
|
0.00%
0/63 • Adverse events were collected from first invasive procedure (during screening) until EOS (Day 160).
|
|
Gastrointestinal Disorders
Gastrointestinal viral infection
|
0.00%
0/63 • Adverse events were collected from first invasive procedure (during screening) until EOS (Day 160).
|
1.5%
1/66 • Adverse events were collected from first invasive procedure (during screening) until EOS (Day 160).
|
0.00%
0/66 • Adverse events were collected from first invasive procedure (during screening) until EOS (Day 160).
|
0.00%
0/62 • Adverse events were collected from first invasive procedure (during screening) until EOS (Day 160).
|
0.00%
0/63 • Adverse events were collected from first invasive procedure (during screening) until EOS (Day 160).
|
|
Nervous System Disorders
Hypersensitivity
|
0.00%
0/63 • Adverse events were collected from first invasive procedure (during screening) until EOS (Day 160).
|
0.00%
0/66 • Adverse events were collected from first invasive procedure (during screening) until EOS (Day 160).
|
1.5%
1/66 • Adverse events were collected from first invasive procedure (during screening) until EOS (Day 160).
|
0.00%
0/62 • Adverse events were collected from first invasive procedure (during screening) until EOS (Day 160).
|
0.00%
0/63 • Adverse events were collected from first invasive procedure (during screening) until EOS (Day 160).
|
|
Hepatobiliary Disorders
Hypertransaminasaemia
|
1.6%
1/63 • Adverse events were collected from first invasive procedure (during screening) until EOS (Day 160).
|
0.00%
0/66 • Adverse events were collected from first invasive procedure (during screening) until EOS (Day 160).
|
0.00%
0/66 • Adverse events were collected from first invasive procedure (during screening) until EOS (Day 160).
|
0.00%
0/62 • Adverse events were collected from first invasive procedure (during screening) until EOS (Day 160).
|
0.00%
0/63 • Adverse events were collected from first invasive procedure (during screening) until EOS (Day 160).
|
|
Metabolism and Nutrition Disorders
Pancreatitis
|
0.00%
0/63 • Adverse events were collected from first invasive procedure (during screening) until EOS (Day 160).
|
0.00%
0/66 • Adverse events were collected from first invasive procedure (during screening) until EOS (Day 160).
|
1.5%
1/66 • Adverse events were collected from first invasive procedure (during screening) until EOS (Day 160).
|
0.00%
0/62 • Adverse events were collected from first invasive procedure (during screening) until EOS (Day 160).
|
0.00%
0/63 • Adverse events were collected from first invasive procedure (during screening) until EOS (Day 160).
|
|
Infections and Infestations
Pneumonia
|
1.6%
1/63 • Adverse events were collected from first invasive procedure (during screening) until EOS (Day 160).
|
0.00%
0/66 • Adverse events were collected from first invasive procedure (during screening) until EOS (Day 160).
|
0.00%
0/66 • Adverse events were collected from first invasive procedure (during screening) until EOS (Day 160).
|
0.00%
0/62 • Adverse events were collected from first invasive procedure (during screening) until EOS (Day 160).
|
0.00%
0/63 • Adverse events were collected from first invasive procedure (during screening) until EOS (Day 160).
|
|
Infections and Infestations
Post-acute COVID-19 syndrome
|
1.6%
1/63 • Adverse events were collected from first invasive procedure (during screening) until EOS (Day 160).
|
0.00%
0/66 • Adverse events were collected from first invasive procedure (during screening) until EOS (Day 160).
|
0.00%
0/66 • Adverse events were collected from first invasive procedure (during screening) until EOS (Day 160).
|
0.00%
0/62 • Adverse events were collected from first invasive procedure (during screening) until EOS (Day 160).
|
0.00%
0/63 • Adverse events were collected from first invasive procedure (during screening) until EOS (Day 160).
|
|
Renal and Urinary Disorders
Pyelonephritis
|
0.00%
0/63 • Adverse events were collected from first invasive procedure (during screening) until EOS (Day 160).
|
0.00%
0/66 • Adverse events were collected from first invasive procedure (during screening) until EOS (Day 160).
|
0.00%
0/66 • Adverse events were collected from first invasive procedure (during screening) until EOS (Day 160).
|
0.00%
0/62 • Adverse events were collected from first invasive procedure (during screening) until EOS (Day 160).
|
1.6%
1/63 • Adverse events were collected from first invasive procedure (during screening) until EOS (Day 160).
|
|
Blood and Lymphatic System Disorders
Sepsis
|
1.6%
1/63 • Adverse events were collected from first invasive procedure (during screening) until EOS (Day 160).
|
0.00%
0/66 • Adverse events were collected from first invasive procedure (during screening) until EOS (Day 160).
|
0.00%
0/66 • Adverse events were collected from first invasive procedure (during screening) until EOS (Day 160).
|
0.00%
0/62 • Adverse events were collected from first invasive procedure (during screening) until EOS (Day 160).
|
0.00%
0/63 • Adverse events were collected from first invasive procedure (during screening) until EOS (Day 160).
|
Other adverse events
| Measure |
BrainHQ Active Comparator
n=63 participants at risk
5 sessions/week at 30 min/session
BrainHQ/Active Comparator Activity: BrainHQ platform provides a set of cognitive activities, like puzzles and games, that are cognitively stimulating and actively engage participants but do not continuously and adaptively challenge them. These activities are designed to be a face-valid, active comparison approach to cognitive therapy, thus participants are blinded, attention time is matched, and overall user experience is identical to the active arms.
|
BrainHQ
n=66 participants at risk
5 sessions/week at 30 min/session
BrainHQ: BrainHQ is an online cognitive training program, and has been used to improve cognitive function among persons with cognitive impairment based on principles of neuroplasticity.
|
BrainHQ + PASC CoRE
n=66 participants at risk
BrainHQ plus 9 group sessions at 1.5 hr/session and 3 individual sessions at 1 hr/session
BrainHQ: BrainHQ is an online cognitive training program, and has been used to improve cognitive function among persons with cognitive impairment based on principles of neuroplasticity.
PASC CoRE: PASC CoRE is a manualized, adaptable cognitive rehabilitation intervention adapted from Goal Management Training and other evidence based programs that improve attention and executive functions, among other cognitive domains.
|
Brain HQ + tDCS-active
n=62 participants at risk
2.0 mA stimulation delivered for 30 min during each BrainHQ session
BrainHQ: BrainHQ is an online cognitive training program, and has been used to improve cognitive function among persons with cognitive impairment based on principles of neuroplasticity.
tDCS-active: Transcranial direct current stimulation (tDCS) will use a device specifically for home-based use. This device delivers a weak electrical current of 2.0 mA passed through two electrodes placed on the scalp to target the dorsolateral prefrontal cortex region of the brain. The electrodes are single-use for each session and can be attached to a headset by snapping into place.
The device has a user-friendly interface and a large-button keypad, making it is easy to use at home.
|
Brain HQ + tDCS-sham
n=63 participants at risk
Inactive stimulation delivered for 30 min during each BrainHQ session
BrainHQ: BrainHQ is an online cognitive training program, and has been used to improve cognitive function among persons with cognitive impairment based on principles of neuroplasticity.
tDCS-sham: tDCS devices used in the sham arm will be pre-programmed to deliver the same ramp up/down at the beginning/end of the 30-minute period as the active arm, except with no current otherwise delivered during the session.
|
|---|---|---|---|---|---|
|
Nervous System Disorders
Migraine
|
0.00%
0/63 • Adverse events were collected from first invasive procedure (during screening) until EOS (Day 160).
|
1.5%
1/66 • Adverse events were collected from first invasive procedure (during screening) until EOS (Day 160).
|
0.00%
0/66 • Adverse events were collected from first invasive procedure (during screening) until EOS (Day 160).
|
0.00%
0/62 • Adverse events were collected from first invasive procedure (during screening) until EOS (Day 160).
|
3.2%
2/63 • Adverse events were collected from first invasive procedure (during screening) until EOS (Day 160).
|
|
Eye Disorders
Vision blurred
|
0.00%
0/63 • Adverse events were collected from first invasive procedure (during screening) until EOS (Day 160).
|
0.00%
0/66 • Adverse events were collected from first invasive procedure (during screening) until EOS (Day 160).
|
0.00%
0/66 • Adverse events were collected from first invasive procedure (during screening) until EOS (Day 160).
|
0.00%
0/62 • Adverse events were collected from first invasive procedure (during screening) until EOS (Day 160).
|
1.6%
1/63 • Adverse events were collected from first invasive procedure (during screening) until EOS (Day 160).
|
|
Psychiatric Disorders
Bruxism
|
0.00%
0/63 • Adverse events were collected from first invasive procedure (during screening) until EOS (Day 160).
|
1.5%
1/66 • Adverse events were collected from first invasive procedure (during screening) until EOS (Day 160).
|
0.00%
0/66 • Adverse events were collected from first invasive procedure (during screening) until EOS (Day 160).
|
0.00%
0/62 • Adverse events were collected from first invasive procedure (during screening) until EOS (Day 160).
|
0.00%
0/63 • Adverse events were collected from first invasive procedure (during screening) until EOS (Day 160).
|
|
Nervous System Disorders
Cognitive disorder
|
0.00%
0/63 • Adverse events were collected from first invasive procedure (during screening) until EOS (Day 160).
|
0.00%
0/66 • Adverse events were collected from first invasive procedure (during screening) until EOS (Day 160).
|
0.00%
0/66 • Adverse events were collected from first invasive procedure (during screening) until EOS (Day 160).
|
1.6%
1/62 • Adverse events were collected from first invasive procedure (during screening) until EOS (Day 160).
|
0.00%
0/63 • Adverse events were collected from first invasive procedure (during screening) until EOS (Day 160).
|
|
Nervous System Disorders
Headache
|
0.00%
0/63 • Adverse events were collected from first invasive procedure (during screening) until EOS (Day 160).
|
1.5%
1/66 • Adverse events were collected from first invasive procedure (during screening) until EOS (Day 160).
|
0.00%
0/66 • Adverse events were collected from first invasive procedure (during screening) until EOS (Day 160).
|
0.00%
0/62 • Adverse events were collected from first invasive procedure (during screening) until EOS (Day 160).
|
1.6%
1/63 • Adverse events were collected from first invasive procedure (during screening) until EOS (Day 160).
|
|
Skin and Subcutaneous Tissue Disorders
Dermatitis atopic
|
0.00%
0/63 • Adverse events were collected from first invasive procedure (during screening) until EOS (Day 160).
|
0.00%
0/66 • Adverse events were collected from first invasive procedure (during screening) until EOS (Day 160).
|
0.00%
0/66 • Adverse events were collected from first invasive procedure (during screening) until EOS (Day 160).
|
1.6%
1/62 • Adverse events were collected from first invasive procedure (during screening) until EOS (Day 160).
|
0.00%
0/63 • Adverse events were collected from first invasive procedure (during screening) until EOS (Day 160).
|
|
Skin and Subcutaneous Tissue Disorders
Thermal burn
|
0.00%
0/63 • Adverse events were collected from first invasive procedure (during screening) until EOS (Day 160).
|
0.00%
0/66 • Adverse events were collected from first invasive procedure (during screening) until EOS (Day 160).
|
0.00%
0/66 • Adverse events were collected from first invasive procedure (during screening) until EOS (Day 160).
|
1.6%
1/62 • Adverse events were collected from first invasive procedure (during screening) until EOS (Day 160).
|
0.00%
0/63 • Adverse events were collected from first invasive procedure (during screening) until EOS (Day 160).
|
|
Psychiatric Disorders
Insomnia
|
0.00%
0/63 • Adverse events were collected from first invasive procedure (during screening) until EOS (Day 160).
|
0.00%
0/66 • Adverse events were collected from first invasive procedure (during screening) until EOS (Day 160).
|
0.00%
0/66 • Adverse events were collected from first invasive procedure (during screening) until EOS (Day 160).
|
0.00%
0/62 • Adverse events were collected from first invasive procedure (during screening) until EOS (Day 160).
|
1.6%
1/63 • Adverse events were collected from first invasive procedure (during screening) until EOS (Day 160).
|
|
General Disorders
Malaise
|
0.00%
0/63 • Adverse events were collected from first invasive procedure (during screening) until EOS (Day 160).
|
0.00%
0/66 • Adverse events were collected from first invasive procedure (during screening) until EOS (Day 160).
|
0.00%
0/66 • Adverse events were collected from first invasive procedure (during screening) until EOS (Day 160).
|
3.2%
2/62 • Adverse events were collected from first invasive procedure (during screening) until EOS (Day 160).
|
0.00%
0/63 • Adverse events were collected from first invasive procedure (during screening) until EOS (Day 160).
|
|
Eye Disorders
Visual impairment
|
0.00%
0/63 • Adverse events were collected from first invasive procedure (during screening) until EOS (Day 160).
|
0.00%
0/66 • Adverse events were collected from first invasive procedure (during screening) until EOS (Day 160).
|
0.00%
0/66 • Adverse events were collected from first invasive procedure (during screening) until EOS (Day 160).
|
1.6%
1/62 • Adverse events were collected from first invasive procedure (during screening) until EOS (Day 160).
|
0.00%
0/63 • Adverse events were collected from first invasive procedure (during screening) until EOS (Day 160).
|
|
Nervous System Disorders
Tension headache
|
0.00%
0/63 • Adverse events were collected from first invasive procedure (during screening) until EOS (Day 160).
|
0.00%
0/66 • Adverse events were collected from first invasive procedure (during screening) until EOS (Day 160).
|
0.00%
0/66 • Adverse events were collected from first invasive procedure (during screening) until EOS (Day 160).
|
1.6%
1/62 • Adverse events were collected from first invasive procedure (during screening) until EOS (Day 160).
|
0.00%
0/63 • Adverse events were collected from first invasive procedure (during screening) until EOS (Day 160).
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place